DATA SAFETY MONITORING PLAN

DSMP概述：由Winship癌症研究所(WCI)及其 临床试验办公室(CTO)需要有一个数据安全和监控计划(DSMP)， 描述如何对研究的安全性和数据完整性进行审核，包括报告不良反应 事件。Dsmp的一般要素是：(1)不良事件报告，包括对 不良事件确定/报告程序；拟议的不良事件报告时间表； 关于谁将收到不良事件报告的决定；(2)数据、安全和进展 报告数据提交和监测的时间表；(3)触发研究结束的规则 包括根据重大风险实施研究结束的规则和程序； 益处，或研究无效性的确定和去盲/去掩蔽的程序和指南；(4) 确保数据机密性和学习隐私保护的方法；(5)PI 进行正在考虑进行的特定临床研究的资格。这个 监测办公室将协调、实施和/或监督所有临床试验监测。所有调查员均已启动 干预试验将每年进行一次审计。监测委员会(DSMC)将审查 每年监测现行议定书活动的所有报告。这些审查是对 IRB制定的报告要求，可能包括半年报告和年度报告 报告。Dsmc还将负责监督所有由调查员发起的第一阶段试验。

Overview of DSMP: Every clinical study conducted by the Winship Cancer Institute (WCI) and its Clinical Trials Office (CTO) is required to have a data safety and monitoring plan (DSMP) that describes how the study will be audited for safety and data integrity including the reporting of adverse events. The general elements of a DSMP are (1) Adverse Event Reporting, including a description of adverse event determination/reporting procedures; proposed adverse event reporting schedules; determination regarding who is to receive adverse event reports; (2) Data, Safety and Progress Reporting with a timetable for data submission and monitoring; (3) Rules to trigger study closure including the rules and processes for implementing study closure based upon significant risks, benefits, or study futility determination and procedures and guidelines for unblinding/unmasking; (4) Methods for ensuring protection of data confidentiality and study privacy; and (5) Review of PI qualifications to conduct the particular clinical study for which DSMP is being considered. The Monitoring Office will coordinate, conduct and/or oversee all clinical trial monitoring. All investigatorinitiated interventional trials will be audited annually. The Monitoring Committee (DSMC) will review all reports of monitoring activities of active protocols annually. These reviews are in addition to the reporting requirements established by the IRB, which may include semi-annual as well as annual reports. The DSMC will also be responsible for overseeing all Phase I investigator-initiated trials.